Smiths Medical Recalls Embryo Replacement Catheters Due to Transfer Failure
Smiths Medical ASD, Inc. is recalling Wallace Sure-Pro Two Stage Embryo Replacement Catheters because the catheter may fail to pass through the outer sheath during embryo transfer.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a functional defect in a medical device used for embryo transfer. While no injuries or illnesses are reported, the failure of the device to perform its intended function during a medical procedure represents a risk of harm, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Smiths Medical ASD, Inc. is recalling 4,910 units of Wallace Sure-Pro Two Stage Embryo Replacement Catheters for difficult transfer with Stylet. The recall involves specific lot codes: 2000103, 2025752, 2161556, 2165854, 2170929, 2304190, and 2363603. These medical devices are used for the introduction of embryos into the uterine cavity following in vitro fertilization.
The recall was initiated because the catheter is unable to pass through the outer sheath during the embryo transfer procedure. This defect prevents the clinician from advancing the inner catheter through the outer sheath to perform the transfer. The agency has classified this recall as Class II.
The affected products were distributed worldwide, including the United States and numerous international markets. Healthcare providers and facilities that possess these specific lot codes should stop using the devices and contact Smiths Medical ASD, Inc. for instructions on return or replacement.
The recalled product
- Product
- Wallace Sure-Pro¿ Two Stage Embryo Replacement Catheter for difficult transfer with Stylet PPS623 Sure-Pro¿ Embryo Replacement Catheters are used for the introduction of embryos into the uterine cavity following in vitro fertilization. Sure-Pro Ultra¿ Embryo Replacement…
- Manufacturer
- Smiths Medical ASD, Inc.
- Affected units
- 4,910
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- Lot Code: 2000103
- 2025752
- 2161556
- 2165854
- 2170929
- 2304190
- 2363603
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 6 recalled by Smiths Medical ASD, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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